Evaluation of Synchrony in the Post-operative Patient (SYNCHRONY)

January 21, 2015 updated by: Hospices Civils de Lyon

Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support)

Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre Bénite, France, 69310
        • Hospices Civils de Lyon- Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult > 18 yr-old
  • abdominal post-operative patient
  • able to trigger the ventilator

Exclusion Criteria:

  • infant
  • pregnancy
  • esophageal surgery
  • recent esophageal variceal bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAVA
Device: MAQUET SERVOi ventilator with Edi Catheter
NAVA respiratory modality
Other Names:
  • Neurally Adjusted Ventilatory Assist
Placebo Comparator: Pressure support
Device: MAQUET SERVOi ventilator
Pressure Support
Other Names:
  • Pressure Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asynchrony index (AI)
Time Frame: 8 hours
Number of asynchrony events/total respiratory rate
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2/FiO2 ratio
Time Frame: 8 hours
ratio of partial pressure arterial oxygen and fraction of inspired oxygen
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Florent WALLET, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010.646

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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